Two New Drugs for Multiple Sclerosis
The FDA has recently approved two
new oral drugs for the treatment of Multiple Sclerosis (MS).
Over the last few years, three
oral drugs for MS have become available: Gilenya came to the US market in 2010;
Aubagio was released in 2012; and Tecfidera in 2013. Prior to that, all
therapies were injectables.
Mavenclad (cladribine), an
oral form of an older drug, given intravenously for certain types of leukemia,
was FDA approved for the treatment of relapsing forms of MS including active secondary progressive disease
in adults. As a result of its safety profile, it’s generally recommended for
patients who have had an inadequate response to, or are unable to tolerate, an
alternate drug indicated for the treatment of MS. Treatment with Mavenclad may
increase the risk of malignancy.
Uniquely, Mavenclad is only administered
twice over four or five days, for two treatment courses which are spaced about
a year apart. After that, the patient doesn’t receive any medication for at
least two years. The dose is weight-based; the total annual cost for an average
80kg person (176 lbs) is $127,900. Though it’s given much less frequently than
any of the other currently available monthly oral medications, it is more
expensive per month ($10,661).
Mayzent (siponimod), was
approved for the same indication. The dose is also unusual: 0.25 mg once daily
on Days 1 and 2; 0.5 mg once daily on Day 3; 0.75 mg once daily on Day 4; 1.25
mg once daily on Day 5. The maintenance dose is 2 mg once daily beginning on
Day 6. The monthly cost is $8,729.
Only time will tell how these
two new drugs will perform in the Multiple Sclerosis landscape.
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